Navigating consent and dissent in early childhood research: An Australian perspective
Katie Fielding, Karen Murcia, Madeleine Dobson, Geoffrey Lowe
Issues in Educational Research, March 2025; 35(1)
Open Access
Abstract
Notions of consent, including assent and dissent, are paramount ethical considerations in human research, but have different connotations in research involving young children (aged 3 to 8). While discussion surrounding consent in the early childhood literature has progressed from paternalistic views surrounding the need to protect the child, to recognising their capacity to make decisions in line with their rights, needs and interests, some studies suggest that the application of this change may still be problematic in practice. Many researchers still grapple with notions of who provides consent, what consent may look like, and how it is applied both before and during research. This article reports on the practical application of consent, framed by the hierarchy of Children’s Participation Rights (Mayne et al., 2018), within a study into young children’s demonstration of creative thinking behaviours when using digital technologies. It provides a brief overview of contemporary views of children’s rights and consent for context before outlining the study itself and how consent was applied throughout, informed by the Mayne et al. (2018) framework. It presents a series of vignettes describing elements of consent as they arose in practice and discusses them in relation to the literature. The article concludes by considering rights-based consent in contemporary early childhood research in terms of study design for future researchers to consider.
Readability of health research informed consent forms: case of the National Health Research Ethics Committee in Tanzania
Readability of health research informed consent forms: case of the National Health Research Ethics Committee in Tanzania
Renatha Kato, Renatha Joseph, Lazaro Haule, Mwanaidi Kafuye
BMC Medical Ethics, 22 April 2025
Open Access
Abstract
Background
Obtaining informed consent is the practice of respect for persons that gives the right to participants to make autonomous decisions about research participation. The difficult-to-read research informed consent forms (RICFs) hinder comprehension and can expose participants to harm. This study aims to assess the readability of health RICFs for studies approved by the National Health Research Ethics Committee (NatHREC) in Tanzania.
Methods
We used a retrospective cross-sectional study design. A total of 266 RICFs were sampled from the NatHREC database using stratified and systematic random sampling strategies. The readability of RICFs was assessed using the Flesch Reading Ease (FRE) and Flesch-Kincaid Readability Grade Level (FKRGL) formulas available in Microsoft Word Office and by manual check. Data were collected using the assessment checklist, analyzed, and presented with SPSS and MS Excel software.
Results
Out of 266 RICFs assessed, 65.4% had the recommended page numbers, 81.6% had longer sentences, and 80.5% were difficult to read, necessitating a person to acquire a US grade 10 (Form Four educational level in Tanzania) to understand the presented information. Pearson’s correlation coefficient with p-values of < 0.001 and 95% confidence level disclosed that sentence lengths in the RICFs had a statistical association with the difficult reading levels obtained.
Conclusion
Findings from this study showed that most of the RICFs were concise in terms of page numbers and word count but had long and difficult sentences. Researchers should assess the readability of RICFs before submitting them for ethical approval. Research Ethics Committees (RECs) should consider inclusion of RICFs readability measurements in the Ethics Guidelines for Health Research. The study recommends further studies to assess the Kiswahili versions of RICFs to determine if the results obtained in this study apply to Kiswahili texts.
Informed Consent in Tertiary Care Hospitals of Pakistan; The Moral Magic of Consent
Informed Consent in Tertiary Care Hospitals of Pakistan; The Moral Magic of Consent
Nargis Khan, Gul Hassan Sethar, Zia Ullah Khan, Lubna Meraj, Nadia Shams, Farhat Bashir
Journal of Rawalpindi Medical College, 29 March 2025
Abstract
Objective
This study aimed to assess whether standard international guidelines obtain informed consent and to identify potential contributing factors.
Methodology
This Questionnaire descriptive cross-sectional study was conducted at public sector hospitals of Karachi (October 2021-Aug. 2022) after ethical approval. A 12-point questionnaire was developed based on three categories, first to assess awareness & significance of IC, second regarding elements of IC & third for administrative part of IC. Indoor adult patients ≥18 years of age, who have undergone any surgical or medical procedures were included. The critically ill, unconscious and those unable to give consent were excluded. Data was analyzed by SPSS version 23.
Results
A total of 587 subjects were included, with a mean age of 43. There were 340(57.9%) males & 247(42.1%) females. 51.7% of respondents had an education level of <10 years. 51.1% & 48.9 % of subjects underwent medical related & surgical related procedures respectively. 426(72.6%) patients were aware of IC and 318(54.2%) responded affirmative to significance of IC. 407(69.3%) subjects were informed about treatment options prior to procedure, 349(59.5%) were informed about complications, while risks & benefits of procedure were discussed with 294(50.1%). 281(47.9%) of the patients were satisfied with the information about the procedure, and 288(49.1%) subjects understood the information. Of the respondents, 356(60.6%) stated that the language used wasn’t appropriate for comprehension, 200(34.1%) identified language as a barrier, 185(31.5%) pointed to cultural factors, and 202(34.4%) believed that both language and culture were barriers to IC. 368(62.7%) of the subjects signed the IC, while the IC was signed by a family member in 219(37.3%). Only a minority of patients, 199(33.9%), felt that the consent process was free and fair, while 388(66.1%) believed their decision was influenced. Among them, 233(39.7%) felt influenced by the doctor, and 155(26.4%) attributed the influence to a family member.
Conclusion
There is significant room for improvement in achieving legally and ethically valid informed consent (IC). Literacy, language barriers, and cultural beliefs are major factors influencing patient’s understanding of IC. Higher levels of education were associated with better comprehension of IC. The majority of patients reported that the consent process was neither free nor fair, with language and cultural barriers being significant obstacles. Enhancing the communication skills of healthcare professionals and incorporating formal training on obtaining IC at all levels, from undergraduate education to consultant training, is suggested.
Informed Consent as a Fundamental Principle of Medical Ethics: An Examination of its Application in Nigerian Healthcare Settings
Informed Consent as a Fundamental Principle of Medical Ethics: An Examination of its Application in Nigerian Healthcare Settings
Onyegbule Kelechi Goodluck
Journal of Commercial and Property Law, 23 March 2025
Abstract
The patient’s right of consent to any medical treatment recommended by a medical practitioner is now internationally recognised. This consent is required by the premise of the individual’s inviolable right to choose and control his own health-care situations. Consent must be free, prior, and informed. Free indicates that permission is invalid if obtained through manipulation or coercion. Consent gained unwillingly, under duress or coercion, may result in a battery lawsuit. The consent must be granted voluntarily by a patient who has capacity to so do. Prior means that consent must be obtained adequately in advance of any authorisation granted by medical or hospital authorities, or the initiation of hospital activities that influence the patient’s health. Informed means that the patient’s agreement must be obtained only after complete and legally accurate disclosure of information about the proposed medical operation. The disclosure must be in a form that is both accessible and clear to the patient, including the nature, scope, duration, potential hazards, and foreseeable consequences of the medical operation. There must be complete disclosure of information about the treatment, benefit, danger, complications, and repercussions of such a procedure. Regarding a procedure or therapy that needs to be administered to the patient, the doctor gives all the information that is required. In Nigeria, the idea of informed, prior, and free consent is not widely recognized in the medical field. This is caused by multiple variables. First, there is the issue of Nigeria’s low literacy rate. Patients with limited literacy typically depend solely on the doctor’s judgement. The second factor is the lack of enforcement of the right to informed consent. Under Nigerian law, patients whose rights to informed consent have been violated have little recourse options. Bureaucracy also hinders the processes that are in place to enforce the right to informed consent. This article makes the case that the legal and institutional regimes for Nigeria’s informed consent laws are insufficient.
Expectations for meaningful free, prior, and informed consent: an exploration by the Little Salmon/Carmacks First Nation
Expectations for meaningful free, prior, and informed consent: an exploration by the Little Salmon/Carmacks First Nation
Original Article
Emily Martin, The Little Salmon Carmacks First Nation, Ben Bradshaw
The Extractive Industries and Society, September 2025
Abstract
Indigenous self-determination plays an increasingly prominent role in lands and resources development decisions. One way of operationalizing self-determination is through the realization of free, prior, and informed consent (FPIC) for development impacting Indigenous Peoples and their lands, as recognized in the United Nations Declaration on the Rights of Indigenous peoples (UNDRIP). In the Yukon, Canada, where some consent and consent-like rights are held by First Nations, few First Nations have formally articulated their expectations for the meaningful expression of their consent. This paper begins to address this gap based on a case study by the Little Salmon/Carmacks First Nation (LS/CFN), a self-governing, Northern Tutchone Yukon First Nation located proximate to past, present, and potentially future mineral development. Though LS/CFN’s expectations of FPIC are not formalized today, this exploratory research presents that LS/CFN participants expect: early engagement; to be fully informed; space for self-defined internal processes; ongoing engagement with proponents and the Crown; mitigation of resource barriers; enforceability of commitments; contextually relevant processes; appropriate representation; agreed upon definitions of terminology; mitigation of power imbalances; and mutual agreement on the consent process itself. More broadly this article makes a case for a covenantal, rather than a solely contractual, approach to make FPIC meaningful.
Beyond Consent: Ensuring Meaningful Protection of Genetic Data Under India’s Digital Personal Data Protection Act, 2023
Beyond Consent: Ensuring Meaningful Protection of Genetic Data Under India’s Digital Personal Data Protection Act, 2023
Review Article
RK Singh, Vini Singh
Journal of Indian Academy of Forensic Medicine, 10 April 2025
Open Access
Abstract
India’s Digital Personal Data Protection Act (DPDPA) adopts a notice-and-consent-based framework for data protection; it treats all personal data, including genetic data, as a singular category without accounting for its unique characteristics. Unlike ordinary personal data, genetic data is inherently relational; it reveals information not just about an individual but also their biological relatives. Moreover, the risks associated with the processing of genetic data extend beyond identifiability, such as the potential for its misuse in law enforcement or to discriminate in matters of employment or insurance. Despite these concerns, the DPDPA fails to offer a nuanced regulatory approach, lacks a clear definition of genetic data, and does not impose heightened safeguards for its processing.
This article identifies the limitations of the DPDPA’s notice-and-consent-based model in regulating genetic data processing and argues for a shift toward a harm-based framework. It proposes key reforms, such as the classification of genetic data into categories based on sensitivity, an expanded definition of the data principal to include affected blood relatives, and risk-based processing guidelines that categorize genetic data processing into prohibited, high-risk, medium-risk, and low-risk processing. Additionally, this article advocates for stronger privacy by design and by default requirements, mandatory data protection impact assessments (DPIAs), and the introduction of rights such as data portability and right to restrict processing.
Further, to ensure effective enforcement, it recommends strengthening grievance redressal mechanisms, introducing compensation for privacy harms, and imposing proportionate criminal liability for negligent handling of sensitive genetic data.
By addressing these gaps, this article underscores the need for a strong legal framework that moves beyond notice and consent to provide meaningful privacy protections for genetic data in India’s evolving digital landscape.
Patient’s Right to Consent to Medical Procedures from the Perspective of Health Law, Bioethics, and Human Rights
Patient’s Right to Consent to Medical Procedures from the Perspective of Health Law, Bioethics, and Human Rights
Ni Putu Parvathi Priyadarshini, Gusti Ayu Putri Kartika
Journal of Law Politic and Humanities, March 2025
Abstract
The patient’s right to consent to medical procedures is a vital element in the relationship between patients and healthcare providers, connected to health law, bioethics, and human rights, all focusing on the protection of patient autonomy. This study analyzes the patient’s right to consent from the perspectives of health law, bioethics, and human rights, and identifies challenges in its implementation in Indonesia. A normative method is employed with legislative, conceptual, and comparative approaches. Data is gathered by analyzing national regulations, bioethical principles, and literature on human rights. Descriptive-analytical analysis was used to explore the synergy between these three perspectives in medical consent implementation. Findings reveal that the patient’s right to consent is regulated by Law No. 17 of 2023 and other relevant regulations. Bioethics stresses respecting patient autonomy, while human rights ensure access to information and the freedom to consent. Challenges include paternalistic cultural attitudes, low public awareness, and inadequate healthcare facilities. Recommendations include strengthening regulations, providing bioethics training for healthcare professionals, and educating the public to safeguard patient rights in medical procedures in accordance with health law, bioethics, and human rights.
On the Legal Dilemma and the Way Out of Revocation of Consent by Living Organ Transplant Donors
On the Legal Dilemma and the Way Out of Revocation of Consent by Living Organ Transplant Donors
Jie Xi, Lei Feng
Open Access Library Journal, March 2025
Abstract
This paper’s purpose is to discuss the legal dilemma arising from the revocation of consent by donors in living organ transplantation, analyze its jurisprudential basis and practical impact, and propose a solution to balance the rights and interests of donors and recipients, so as to promote the healthy development of the organ transplantation cause. Through the analysis of typical cases, it reveals the real harm of revocation of consent; combined with the legislative status of China’s Human Organ Transplantation Regulations, it points out the deficiencies of the current law in the definition of conditions, procedures and consequences of the exercise of the right of revocation; from the perspective of jurisprudence, it demonstrates the legitimacy of the revocation of consent, and emphasizes that it is in line with the principle of voluntariness, personal autonomy, and social adaptability of the law; through the comparative study, it compiles the legal difficulties in the protection of donor autonomy, information and notification mechanism, and psychological and social impacts in the US and Germany. Through comparative legal research, the practical experience of the United States and Germany in protecting the autonomy of donors, the information mechanism and the psychological counseling system is examined; specific conditions limiting the exercise of the right of revocation are proposed, including time, form and force majeure factors, and a framework of legislative proposals is constructed based on them.
Editor’s Note: The revocation of consent referred to in this article occurs prior to surgery taking place.
A cross-sectional analysis of the reliability, content and readability of orthodontic retention and retainer informed consent forms
A cross-sectional analysis of the reliability, content and readability of orthodontic retention and retainer informed consent forms
Original Article
Maurice J. Meade, Sven Jensen, Xiangqun Ju, David Hunter, Lisa Jamieson
International Orthodontics, September 2025
Open Access
Summary
Objective
The aim of the study was to determine the reliability, quality and readability of content contained within informed consent forms concerning orthodontic retention and retainers provided by orthodontic treatment providers.
Methods
An online search strategy identified informed consent forms for evaluation. The DISCERN instrument was used to determine content reliability. Each form was assessed for the presence of pre-determined content regarding 11 domains. Analysis for quality of the domain content was via a 4-point scoring scale. The Simple Measure of Gobbledegook (SMOG) and the Flesch-Kincaid Grade-Level (FKGL) were employed to determine readability.
Results
Thirty-four forms satisfied selection criteria. The majority (n = 20; 58.8%) were sourced from websites in the US, with most (n = 22; 64.7%) from specialist orthodontist websites. The mean (SD) DISCERN score per form was 31.9 (4.5). The mean (SD) number of domains present within each form was 7.76 (1.65). The mean (SD) number of points scored per form was 14.82 (3.01) from a maximum of 33. Information regarding retainer review and relevant potential impacts on quality-of-life was lacking and scored poorly. The requirement for lifetime retention was stated in 25 (73.5%) forms. Forms sourced from specialist orthodontist websites scored higher (P = 0.016) than those sourced from general dentist and multi-disciplinary clinic websites. The median (IQR) SMOG and FKGL scores were 10.11 (9.55) and 9.95 (9.18) respectively.
Conclusions
The reliability and quality of the informed consent forms concerning orthodontic retention and retainers was generally poor. The readability of the forms failed to meet recommended guidelines, meaning that many are likely not to comprehend the information provided.
Permission to Die? The Conflict of Consent in Brain Death Testing
Permission to Die? The Conflict of Consent in Brain Death Testing
Karrah St. Laurent-Ariot, George Clement, Bailey Brislin, Paul Zimmerman, Laura Hanson
Journal of Pain and Symptom Management, May 2025
Outcomes
- Understand the ethics and laws regarding brain death testing.
- Understand processes of brain death testing in ventilated patients and how these interact with patient and family values.
Key Message
Brain death testing can be inconsistent with patient’s cultural beliefs. While consent is not required to evaluate for brain death, apnea testing for a ventilated patient is an involved process which can be traumatic for families. Moral distress can be reduced by using thorough communication early on to establish a care plan that incorporated her spiritual and cultural beliefs.
Abstract
While there is ongoing debate about the need for consent for brain death testing, American Academy of Neurology guidelines state there is “no obligation to obtain consent”. However, familial objection to brain death testing can present care teams with unique challenges.
Case
An 18-year-old woman was found unresponsive after going to sleep with a severe headache. Evaluation at a local hospital showed respiratory arrest triggering intubation, GCS 3, unresponsive pupils, and hypothermia; CT head demonstrated a large intracranial hemorrhage and evidence of brain herniation. She was transferred to a tertiary medical center where brain death testing was recommended once hypothermia resolved. Her father was initially amenable, but after consultation with faith leaders, declined apnea testing, the remaining step to diagnose brain death. Her hospitalization was complicated by substantial barriers to trust and communication. Her family recounted inconsistent information and policies, over-adherence to algorithms, and shades of historical manipulation of minorities. They employed video surveillance and threats of litigation and requested transfer to New Jersey where brain death criteria are not endorsed. Ultimately, the patient received tracheostomy and PEG and was discharged to a long-term acute care hospital.
Discussion
Apnea testing for a ventilated patient can be traumatic for families. Both the family and the medical team experienced immense moral distress which may have been ameliorated by early and thorough communication to establish a care plan that incorporated her spiritual and cultural beliefs. Only one state in the U.S, New Jersey, allows for religious exemptions to Death by Neurologic Criteria under its Declaration of Death Act. It is often helpful to let family witness serial neurological exams to better understand the condition of their loved ones. Lastly, incorporating palliative care and chaplaincy services can decrease moral distress of both families and medical teams.
Editor’s note: We note the reference to the American Academy of Neurology guidelines and it’s apparent treatment of consent, which we will be examining further within our Center for Informed Consent Integrity.
Center for Informed Consent Integrity 